Children achieve sustained ADHD symptom improvement with long-term, once-daily use of A...( n controlling ADHD symptoms in this stu...),Health

n controlling ADHD symptoms in this study should alleviate the fears of families and physicians that the once daily mixed salts amphetamine product may lose its effectiveness over time. This study documents a robust response which is maintained even when the drug is used in the long term."

The medication was generally well tolerated during the extension trial. The common side effects seen over the 24 months included headache, loss of appetite, insomnia, and abdominal pain. The majority of treatment-emergent side effects were mild and transient, with the majority occurring within the first three months of the extension study. No clinically significant changes in the patients' average heart rates or blood pressure measures occurred. Side effects were similar to those reported in previous short-term trials of the medication. Of the 560 enrollees, 273 (48 percent) completed the study, with only 84 (14.8 percent) withdrawing due to a side effect. The effectiveness of the once daily mixed salts amphetamine product for long-term use, i.e., for more than three weeks, has not been systematically evaluated in controlled trials. Data are inadequate to determine whether chronic use of stimulants in children, including amphetamine, may be causally associated with suppression of growth. At enrollment, the extension trial participants' average age was 8.7 years, 78 percent were boys, 73 percent were white, 12 percent were black, 9 percent were Hispanic and 6 percent had another ethnicity.

Long-Term Mixed Salts Amphetamine Product Treatment Improves Quality of Life in ADHD Children (APA Poster #650) Treatment with a once-daily a mixed salts amphetamine product also significantly enhanced the quality of life of children with ADHD and the improvement persisted during long-term treatment (up to two years), based on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scores. The scores were generated based on parents' perspectives and assessed patients
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Contact: Michle Roy, Shire Pharmaceuticals Group plc
450-978-7938
Porter Novelli
21-May-2003

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